Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-finding Trial of Lu AG09222 for the Prevention of Migraine in Participants With Unsuccessful Prior Preventive Treatments
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 874
- 试验地点
- 229
- 主要终点
- Change From Baseline in the Number of Monthly Migraine Days (MMDs)
研究概览
简要总结
The purpose of this trial is to determine which doses of Lu AG09222 are recommended to help prevent migraines. People who join this trial have already tried 1 to 4 other available medications to prevent their migraines, but these medications have not helped them.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant has a diagnosis of migraine as defined by International Classification of Headache Disorders Third Edition (ICHD-3) guidelines confirmed at the Screening Visit.
- •The participant has a history of migraine onset ≥ 12 months prior to the Screening Visit.
- •The participant has a migraine onset at ≤50 years of age.
- •The participant has ≥4 migraine days per month for each month within the past 3 months prior to the Screening Visit.
- •The participant has documented evidence of treatment failure in the past 10 years of at least 1 to 4 (maximum) different migraine preventive medications.
排除标准
- •The participant has previously been dosed with an anti-pituitary adenylate cyclase-activating peptide (anti-PACAP treatment).
- •The participant has confounding and clinically significant pain syndromes.
- •The participant has a diagnosis of acute or active temporomandibular disorder.
- •The participant has a history or diagnosis of confounding headaches.
- •Additional protocol-defined criteria apply.
研究组 & 干预措施
Group D: Lu AG09222 SC (closed for recruitment)
Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.
干预措施: Placebo (Drug)
Group E: Lu AG09222 SC (closed for recruitment)
Participants will receive 2 injections, each containing Lu AG09222.
干预措施: Lu AG09222 (Drug)
Group F: Placebo IV
Participants will receive placebo by intravenous (IV) infusion.
干预措施: Placebo (Drug)
Group G: Lu AG09222 IV
Participants will receive Lu AG09222 by IV infusion.
干预措施: Lu AG09222 (Drug)
Group H: Lu AG09222 IV
Participants will receive Lu AG09222 by IV infusion.
干预措施: Lu AG09222 (Drug)
Group I: Lu AG09222 IV
Participants will receive Lu AG09222 by IV infusion.
干预措施: Lu AG09222 (Drug)
Group A: Placebo SC (closed for recruitment)
Participants will receive 2 injections of placebo.
干预措施: Placebo (Drug)
Group B: Lu AG09222 SC (closed for recruitment)
Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.
干预措施: Lu AG09222 (Drug)
Group B: Lu AG09222 SC (closed for recruitment)
Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.
干预措施: Placebo (Drug)
Group D: Lu AG09222 SC (closed for recruitment)
Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.
干预措施: Lu AG09222 (Drug)
Group C: Lu AG09222 SC (closed for recruitment)
Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.
干预措施: Lu AG09222 (Drug)
Group C: Lu AG09222 SC (closed for recruitment)
Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Number of Monthly Migraine Days (MMDs)
时间窗: Baseline up to Week 12 (Weeks 1-12)
次要结局
- Percentage of Participants With ≥75% Reduction From Baseline in MMDs(Baseline up to Week 12 (Weeks 1-12))
- Change from Baseline in the Number of Monthly Headache Days(Baseline up to Week 12 (Weeks 1-12))
- Number of Participants with Treatment-emergent Adverse Events (TEAEs)(Up to Week 20)
- Number of Participants with Anti-drug Antibodies (ADA)(Up to Week 20)
- Change From Baseline in MMDs(Baseline up to Week 12 (Weeks 1-12))
- Percentage of Participants With ≥50% Reduction From Baseline in MMDs(Baseline up to Week 12 (Weeks 1-12))